Ultrasound, Hyperthermia, Cancer Treatment

Product Code: LSY

Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:

Radiation Type	Acoustic
Radition Safety	None
Annual Reports	No

Products Classified as LSY

5437

Ultrasound, Hyperthermia, Cancer Treatment

Total Product Life Cycle (TPLC) Devices

5437

Ultrasound, Hyperthermia, Cancer Treatment

FDA Consensus Standards

Ultrasound, Hyperthermia, Cancer Treatment [32412]

21 CFR Unclassified 🔎

Pre-market Approvals for LSY

P040003

EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM

INSIGHTEC, LTD

Global Unique Device Identification Database

07290015461429	Ultrasound,Hyperthermia, Cancer Treatment
07290015461405	Ultrasound,Hyperthermia, Cancer Treatment
07290015461337	Ultrasound,Hyperthermia, Cancer Treatment
07290015461320	Ultrasound,Hyperthermia, Cancer Treatment
07290015461313	Ultrasound,Hyperthermia, Cancer Treatment
07290015461306	Ultrasound,Hyperthermia, Cancer Treatment
07290015461290	Ultrasound,Hyperthermia, Cancer Treatment
07290015461283	Ultrasound,Hyperthermia, Cancer Treatment
07290015461276	Ultrasound,Hyperthermia, Cancer Treatment
07290015461269	Ultrasound,Hyperthermia, Cancer Treatment
07290015461252	Ultrasound,Hyperthermia, Cancer Treatment
07290015461245	Ultrasound,Hyperthermia, Cancer Treatment
07290015461238	Ultrasound,Hyperthermia, Cancer Treatment
07290015461221	Ultrasound,Hyperthermia, Cancer Treatment
07290015461214	Ultrasound,Hyperthermia, Cancer Treatment

Maude Adverse Events

EXABLATE NEURO

INSIGHTEC HAIFA ISRAEL, INSIGHTEC, LTD.

2018-05-02